| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00490-1 |
| Product Name/Description |
ESG-410 Electrosurgical Generator
Material Number: WA91307W
Serial Numbers: 102461, 102463, 102529, 102530, 102531, 102532, 102601, 102602, 102750, 102753, 102767
ARTG 371561
(Olympus Australia Pty Ltd - Electrosurgical system generator, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Olympus Australia have identified an increase in complaints related to the ESG-410 generator not powering on.
Their investigation has determined that this phenomenon is caused by a failure of electrical components on the generator’s power supply. However, if the device has successfully powered on, it will work within specification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
1. Customers are to Inspect their inventory and identify any ESG-410 devices with the serial numbers specified.
2. They may continue to use the product until the power supply is replaced.
An Olympus representative will reach out to customers to coordinate the service to replace the power supply on the affected ESG-410 unit(s) once the acknowledgment form is received. |
| Contact Information |
1300 132 992 - Olympus Customer Operations or oaz-fca@olympus.com |